Danazol treatment of chronic cystic mastopathy: a clinical and hormonal evaluation

Marc Dhont, M DHONT, L. Delbeke, J van Eyck, van Eyck J, L Voorhoof
Postgraduate medical journal · 1979 · vol. 55 Suppl 5 , pp. 66–70 · PMID:395523 · W2443290208
RCT OA: closed CC0 ⤵ 7 in-corpus citations
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Danazol effectively relieved chronic cystic mastopathy symptoms in women, with significant side effects including amenorrhea, irregular bleeding, and weight gain, linked to its ovulation-inhibiting hormonal effects.

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Abstract

Danazol, a new synthetic steroid, was administered at a dose of 400 mg daily for two months to 16 premenopausal women with chronic cystic mastopathy. The clinical and hormonal effects (serum luteinizing hormone (LH), follicle-stimulating hormone (FSH), prolactin, progesterone, testosterone and urinary oestrogens, pregnanediol, pregnanetriol, androsterone and etiocholanolone) were evaluated after 4 and 8 weeks of treatment. Using the same dosage and duration of treatment, danazol (13 patients) was compared with placebo (12 patients) in a double blind randomized clinical trial. Danazol proved to be significantly more effective than placebo in relieving symptoms. Combining the open and double blind study (27 patients), danazol treatment resulted in complete relief in 14 patients and improvement in 11. The main endocrine changes during danazol treatment were related to the drug's ovulation inhibiting effect. Amenorrhoea, irregular bleeding and weight gain (mean 2.1 kg) were significant side effects.

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MeSH descriptors

Breast Diseases Danazol Fibrocystic Breast Disease Pregnadienes Adult Breast Diseases Clinical Trials as Topic Danazol Double-Blind Method Female Fibrocystic Breast Disease Fibrocystic Breast Disease Gonadal Steroid Hormones Gonadal Steroid Hormones Gonadotropins, Pituitary Gonadotropins, Pituitary Humans Middle Aged Pregnadienes

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